Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UF 9676 | Other Identifier | Montpellier University Hospital |
Not provided
Not provided
Modified study and new deposit in RECHMPL21_0451
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Aim of this study is to evaluate in a population of old osteoporotic chronic kidney disease females the effect of denosumab:
Aim of this study is to evaluate in a population of old osteoporotic chronic kidney disease females the effect of denosumab:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Denosumab | Experimental | Denosumab 60 mg, subcutaneous injection every 6 months for 24 months |
|
| Placebo | Placebo Comparator | NaCl 0.9% (1 mL), subcutaneous injection every 6 months for 24 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denosumab | Drug | Patients will receive a subcutaneous injection of Denosumab every 6 months for the duration of the study. In addition, they will receive vitamin D and calcium (which is the normal treatment) for the duration of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Relative variation of femoral bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry) | 24 months after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Relative variation of lumbar bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry) | 24 months after inclusion | |
| Relative variation of coronary calcification scores after 24 months of follow-up | 24 months after inclusion |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jean-Paul CRISTOL, Prof | CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique MĂ©dipole Cabestany | Cabestany | France | ||||
| CHL Castelnau Le Lez |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34231877 | Derived | Hara T, Hijikata Y, Matsubara Y, Watanabe N. Pharmacological interventions versus placebo, no treatment or usual care for osteoporosis in people with chronic kidney disease stages 3-5D. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013424. doi: 10.1002/14651858.CD013424.pub2. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| NaCl (placebo) | Drug | Patients will receive a subcutaneous injection of NaCl every 6 months for the duration of the study. In addition, they will receive vitamin D and calcium (which is the normal treatment) for the duration of the study. |
|
| Relative variation of abdominal aorta calcification scores after 24 months of follow-up | 24 months after inclusion |
| Variation of calcium at 6, 12, 18 and 24 months of follow-up | 6, 12, 18 and 24 months after inclusion |
| Variation of phosphorus at 6, 12, 18 et 24 months of follow-up | 6, 12, 18 and 24 months after inclusion |
| Morbi-mortality at 24 months of follow-up | 24 months after inclusion |
| Adverse events occuring during the entire study | 24 months after inclusion |
| Castelnau-le-Lez |
| France |
| CHU Lyon Sud, Nephrology department | Lyon | France |
| AP-HM, Nephrology department | Marseille | France |
| AIDER | Montpellier | France |
| CHU Montpellier, Nephrology department | Montpellier | France |
| CHU Nice, Nephrology department | Nice | France |
| CHU Nimes, Nephrology department | Nîmes | France |
| CH Perpignan, Nephrology department | Perpignan | France |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D010024 | Osteoporosis |
| D061205 | Vascular Calcification |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002114 | Calcinosis |
| D002128 | Calcium Metabolism Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided